PD-1单抗治疗21例恶性肿瘤晚期患者安全性和疗效的临床观察

目的 观察程序性死亡受体1(PD-1)单抗治疗晚期恶性肿瘤的近期疗效和不良反应.方法 回顾性分析采用PD-1单抗治疗的21例多种恶性肿瘤晚期患者的临床资料,根据治疗方案不同分为Nivolumab(Nivo)治疗11例和Pembrolizumab(Pem)治疗10例.分别采用RECIST 1.1与NCI-CTC 4.0标准评价21例患者的近期疗效和不良反应.结果 采用PD-1单抗治疗的21例患者中,17例可评估疗效,其中9例可评估疗效的Nivo治疗患者中,8例采用PD-1单抗单药治疗,疗效评估为CR 0例、PR 3例(膀胱尿路上皮细胞癌、肾尿路上皮细胞癌、非小细胞肺癌各1例)、SD 5例(膀胱尿路上皮细胞癌、肾尿路上皮细胞癌、恶性黑色素瘤、肾透明细胞癌、非小细胞肺癌各1例)、PD 0例;1例联合用药,疗效评估为SD(肝癌患者采用PD-1单抗联合乐伐替尼治疗).8例可评估疗效的Pem治疗患者中,5例采用PD-1单抗单药治疗,疗效评估为CR 0例、PR 1例(非小细胞肺癌)、SD 3例(肝胆管细胞癌、结肠腺癌合并子宫内膜癌、恶性胸腺瘤各1例)、PD 1例(非小细胞肺癌);3例联合用药,疗效评估为PD 2例(1例前列腺癌患者采用PD-1单抗联合阿比特龙治疗,1例乳腺癌合并宫颈癌患者采用PD-1单抗联合依维莫司、依西美坦治疗)、SD 1例(恶性纤维组织瘤患者采用PD-1单抗联合帕唑帕尼治疗).常见的不良反应多为1~2级,主要表现为疲乏、皮疹和消化道反应等.结论 晚期恶性肿瘤患者对PD-1单抗的耐受性良好,可以选择其作为晚期恶性肿瘤的一种治疗方法.

Analysis of the safety and efficacy of anti-PD-1 antibody for 21 cases with advanced cancer

Objective To abserve the short-term efficacy and adverse reactions of anti-programmed cell death-1(an-ti-PD-1)antibody in treating advanced cancer.Method 21 patients of malignant advanced cancer treated with anti-PD-1 antibody were included in the analysis, and were assigned as Nivo group or Pem group as per the therapy adminis-tered,with 11 cases and 10 cases in each,respectively.The short-term efficacy and adverse reactions were evaluated by RECIST 1.1 and NCI-CTC 4.0 criteria.Result Of the 21 cases treated by anti-PD-1 antibody,17 cases were evaluable, and in 9 evaluable patients treated with Nivo, 8 were administered with anti-PD-1 antibody, 0 reached CR, 3 had PR [bladder urothelia carcinoma,renal urothelia carcinoma,non-small cell lung cancer(NSCLC)],5 achieved SD(bladder urothelia carcinoma,renal urothelia carcinoma,malignant melanoma,renal clear cell carcinoma,non-small cell lung can-cer),and there was no case of PD;1 patient treated with combined therapy had SD(liver cancer,treated with anti-PD-1 antibody plus lenvatinib).In 8 evaluable patients treated with Pem,5 were given anti-PD-1 antibody,no CR,and there was 1 case of PR(NSCLC),3 had SD(hepatocholangiocarcinoma,colon cancer combined with endometrial carcinoma, malignant thymoma), 1 had PD (NSCLC); in 3 patients who were treated with combined therapy, there was 2 cases of PD (1 case of prostate cancer treated with anti-PD-1 antibody plus abiraterone, 1 case of breast cancer combined with cervical cancer treated with anti-PD-1 antibody plus everolimus and exemestane),1 had SD(1 case of malignant fibrous histocytoma treated with anti-PD-1 antibody combined with pazopanib). The most frequently observed adverse events were at grade 1-2, and mainly were fatigue, rash and gastrointestinal reactions. Conclusion Anti-PD-1antibody could be well tolerated in advanced malignant cancer patients,and could be applied as an alternative option for advanced ma-lignant cancer.